Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
NCT ID: NCT04920136
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2021-09-17
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.
Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
Free gingival graft.
Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area will be sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.
Free Gingival graft
Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.
Interventions
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Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
Free Gingival graft
Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Able to read and understand informed consent document
* Patients with teeth/implants lacking keratinized tissue.
* Must be a patient of the UAB Dental School
* Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
Exclusion Criteria
* Less than 18 years old
* Smokers/tobacco users (\>10 cigarettes/day)
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Presence of active periodontal disease
* Previous soft tissue grafting at the site(s) to be treated
18 Years
99 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Hussein Basma
Principal Investigator
Locations
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Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UAB-Perio
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-300006910
Identifier Type: -
Identifier Source: org_study_id
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